Validating to be processes
All products and processes need validation when you cannot verify the process output by monitoring or measuring.
These validations are performed to reduce production costs and ensure regulatory requirements are met.
For FDA approval, the process validation will need to be rationalized and accompanied by appropriate documentation.
To determine if a process requires validation or verification, many factors need to considered carefully.
In either case, you need to know what validation means for you, your customers, and your suppliers.